title: Regulatory responses to over-the-counter codeine analgesic misuse in Australia, New Zealand and the United Kingdom.
abstract: OBJECTIVE
  Analysis of the policy response by Australia's National Drugs and Poisons Schedule Committee (NDPSC) and comparison with recommendations by expert advisory committees in New Zealand and the United Kingdom.
  
  
  METHODS
  Analysis of public policy documents of relevant regulatory authorities was conducted. Data were extracted regarding changes to over-the-counter (OTC) codeine analgesic scheduling, indications, maximum unit dose, maximum daily dose, maximum pack size, warning labels, consumer medicine information and advertising. Where available, public submissions and other issues considered by the committees and rationale for their recommendations were recorded and thematically analysed.
  
  
  RESULTS
  Expert advisory committees in Australia, NZ and the UK defined the policy problem of OTC codeine misuse and harm as small relative to total use and responded by restricting availability. Pharmacist supervision was required at the point-of-sale and pack sizes were reduced to short-term use.
  
  
  CONCLUSIONS
  Comparison with recommendations by expert advisory committees in NZ and the UK suggests the NDPSC's actions in response to OTC codeine misuse were appropriate given the available evidence of misuse and harm, but highlights opportunities to utilise additional regulatory levers.
  
  
  CONCLUSIONS
  Framing policy problems as matters of public health in the context of limited evidence may support decision makers to implement cautionary incremental policy change.
authors.affiliation: School of Public Health and Preventive Medicine, Monash University, Victoria Mental Health, Drugs and Regions Division, Victorian Department of Health Capri Hospital, New Zealand.
authors.forename: Claire L
authors.initials: CL
authors.lastname: Tobin
authors.forename: Malcolm
authors.initials: M
authors.lastname: Dobbin
authors.forename: Brian
authors.initials: B
authors.lastname: McAvoy
mesh_terms: D026683:Advisory Committees; D000701:Analgesics, Opioid / Q000009:adverse effects*; D001315:Australia; D003061:Codeine / Q000009:adverse effects*; D003257:Consumer Product Safety; D004335:Drug and Narcotic Control; D033161:Government Regulation; D006801:Humans; D009520:New Zealand; D004366:Nonprescription Drugs; D011634:Public Health; D011640:Public Policy; D019966:Substance-Related Disorders; D006113:United Kingdom
chemical_list: D000701:Analgesics, Opioid; D004366:Nonprescription Drugs; D003061:Codeine
keywords: analgesics; codeine; drug policy; misuse; non-medical use; over-the-counter drugs